40 Participants Needed

BurstDR Stimulation for Painful Diabetic Neuropathy

MB
Overseen ByMerve Buluk Figueira, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Aurora Health Care
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study aims to demonstrate treatment outcomes of Painful Diabetic Neuropathy (PDN) patients treated with BurstDRTM Spinal Cord Dorsal Column Stimulator (SCS) along with conservative medical management per standard of care.

Research Team

MA

Mansoor Aman, MD

Principal Investigator

Aurora Healthcare

Eligibility Criteria

Inclusion Criteria

You have been afflicted with painful diabetic neuropathy in your lower limbs for at least one year prior to signing the consent form.
Your lower limb pain is rated at 5 cm or higher on the VAS.
You are a suitable candidate for the medical operations specified in this research as per the clinician's evaluation.
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Treatment Details

Participant Groups
1Treatment groups
Experimental Treatment
Group I: PDN treated with SCS and CMMExperimental Treatment1 Intervention
Painful diabetic neuropathy patients treated with burst stimulation along with conservative medical management as part of regular medical care.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aurora Health Care

Lead Sponsor

Trials
46
Recruited
16,400+

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+